NASAL INSERT AND CANNULA AND METHODS FOR THE USE THEREOF
A nasal insert includes a user interface with a housing having a circumferential wall defining an interior passage. A valve is in communication with the interior passage and limits a fluid flow through the interior passage in at least one direction. An exterior surface of the housing is adapted to interface with a nasal vestibule of a user and define an exhalation flow path. Methods of using and assembling the nasal inserts also are provided.
This application claims the benefit of U.S. Provisional Application No. 61/540,740, filed Sep. 29, 2011, entitled “Nasal Insert and Cannula and Methods for the Use Thereof,” the entire disclosure of which is hereby incorporated herein by reference.
TECHNICAL FIELDThe present invention relates generally to a nasal insert, and in particular, to a nasal insert and cannula suitable for the treatment of various sleep disorders, including without limitation sleep apnea.
BACKGROUNDThere are a wide variety of different diseases and physiological disorders associated with breathing, including sleep disorders such as sleep apnea and snoring, chronic obstructive pulmonary disease (CPOD), bronchitis, asthma and others. Many of these diseases and disorders may be treated by modifying the respiratory cycle.
For example, various oral or dental devices, such as the mandibular advancement device (MAD), have been developed for sleep apnea, and may be effective for treatment of mild sleep apnea, especially for patients that sleep on their back or stomach, and may improve airflow for patients with severe sleep apnea. These types of oral/dental devices may not be as effective, however, as continuous positive airway pressure devices (CPAP). Moreover, oral/dental devices are typically expensive, and may be associated with various side effects, including nighttime pain, dry lips, tooth discomfort, rearrangement in tooth and jaw positions, and excessive salivation, one or more of which may lead to reduced patient compliance.
CPAP devices will effectively control sleep apnea, but patient compliance may again be low, due for example to the discomfort of, and claustrophobic feeling associated with, the mask, pressure of the device, noise associated with the machine, entanglement of tubes, etc.
Other devices, as disclosed for example and without limitation in U.S. Pat. No. 7,735,491 to Doshi, U.S. Pat. No. 6,626,179 to Pedley and WO 2007/134458 to Robitaille, have been developed to treat sleep apnea and other respiratory disease and disorders by interfacing with the nasal passage of the user. Many of these types of nasal insert devices, however, may be difficult to properly install and/or use, for example requiring screwing of the device into the nasal passageway. In other systems, a holdfast, which secures the device to the user, may be external to the user, leading to lower levels of comfort and compliance. Conversely, internal holdfast systems may have a limited size variance, leading to such devices being either too tight or too loose, and/or adversely affecting the comfort level of the device and the associated compliance. Indeed, internal holdfast systems are often intended to create a tight seal with the nasal passageway, which may limit the population associated with any particular device.
SUMMARYBriefly stated, in one aspect, one embodiment of a nasal insert includes a housing having a circumferential wall defining an interior passage. The wall has a longitudinal gap extending along a length thereof, with an outer peripheral dimension of the housing being adjustable by varying the gap. A valve is in communication with the interior passage and limits a fluid flow through the interior passage in at least one direction.
In another embodiment, a nasal insert includes a user interface having a tubular housing defining an interior cavity open at opposite ends. An exterior surface of the housing is adapted to interface with a nasal vestibule of a user. A base is received in the interior cavity of the housing and includes an exit port. A cap is connected to the base and has an input port. A valve member is disposed in an interior passage defined by at least one of the cap and base, with the valve member being moveably received in the interior passage.
In yet another aspect, an embodiment of a nasal insert includes a housing including an interior passageway having a polygonal cross-section and a valve member disposed in the interior passageway. The valve member is moveably received in the interior passage and has a different cross-sectional shape than the polygonal cross-section. At least one airflow passageway is formed between the valve member and the interior passageway.
In another embodiment, a nasal insert includes a housing having a longitudinally extending flow passageway and an opening formed in a side thereof transversely to the flow passageway. A valve member is inserted into the flow passageway through the opening. A user interface is disposed around the housing and covers the opening so as to retain the valve member in the flow passageway. In one embodiment, a panel may be provided to cover the opening before the user interface is disposed around the housing.
Various methods of providing resistance during exhalation are also provided. For example, in one embodiment, a method of providing resistance during exhalation includes providing a housing having a circumferential wall defining an interior passage, wherein the wall has a longitudinal gap extending along a length thereof. The method includes squeezing the housing and thereby closing at least a portion of the gap, inserting the housing into a nasal passage of a user while the housing is being squeezed and releasing the housing and thereby letting the gap increase as the housing expands into the nasal passage of the user. The method further includes inhaling through the housing and passing air through a valve in communication with the interior passage and exhaling through the housing and limiting a flow of exhaled air through the interior passage with the valve while passing at least a portion of the exhaled air through the gap.
In another embodiment, a method of providing resistance during exhalation includes compressing a user interface having an exterior tubular housing, inserting the user interface into a nasal passage of a user while the user interface is being compressed, and releasing the user interface and thereby letting the user interface expand into the nasal passage of the user. The method further includes inhaling through an interior housing disposed in the exterior tubular housing, wherein the interior housing is less compressible than the exterior housing and passing air through a valve disposed in the interior housing. The method further includes exhaling through the interior housing and limiting a flow of exhaled air through the interior housing with the valve.
In another aspect, a method of assembling a nasal insert includes inserting a valve member through an opening in the side of a housing, wherein the housing has a longitudinally extending flow passageway, and disposing a user interface around the housing and thereby covering the opening with the user interface so as to retain the valve member in the flow passageway.
The various aspects and embodiments provide significant advantages over other nasal inserts. For example and without limitation, a nasal insert configured with a gap may be easily inserted into a wide population of users with different size nasal passageways. At the same time, the gap provides a defined passageway for the flow of air. In addition, an embodiment configured with a base and cap allows for secure disposal of the valve member, thereby avoiding aspiration into the user's lungs, while providing for a simple and robust design. At the same time, the interface between the valve member and passageway provides for predetermined air flow paths and associated amounts of resistance.
The present invention, together with further objects and advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.
Referring to the drawings, various nasal inserts, nasal insert assemblies and nasal cannula assemblies are shown. The phrase “nasal insert” and “nasal insert assembly” refer to a nasal insert configured to interface with one or both nasal cavities of the user, or in a cavity formed in the user's tracheotomy. The phrase “nasal cannula” of “nasal cannula assembly” refers to a nasal insert or assembly coupled to a delivery tube configured to deliver oxygen or other gases.
The terms “longitudinal” and “axial” as used herein relates to a length or lengthwise direction, including for example generally the direction of flow of fluids through the nasal inserts and assemblies. The term “lateral” and variations thereof refer to a sideways direction. The terms “top” and “bottom” are intended to indicate directions when viewing the nasal insert when positioned for insertion into the nasal cavity of the user, with the “top” end thereof being inserted first. However, it should be understood that a user can use the nasal insert and assembly, and cannula assembly, when the user is in any number of positions, including but not limited to an upright position (seated or standing) or horizontal position (whether lying sideways, prone or supine).
It should be understood that the term “plurality,” as used herein, means two or more. The term “coupled” means connected to or engaged with, whether directly or indirectly, for example with an intervening member, and does not require the engagement to be fixed or permanent, although it may be fixed or permanent. The term “transverse” means extending across an axis, including without limitation substantially perpendicular to an axis. It should be understood that the use of numerical terms “first,” “second,” “third,” etc., as used herein does not refer to any particular sequence or order of components; for example “first” and “second” housing members may refer to any sequence of such members, and is not limited to the first and second indicator members of a particular configuration unless otherwise specified. It should be understood that the terms “input port” and “exit port” refer to the function of the ports during an inhalation phase, and that those same ports serve the opposite function (input and exit) during an exhalation phase.
Referring to
The nasal insert 2 may be configured as a single unit, which is suitable for independent and separate insertion into a single nasal cavity of the user or tracheomoty, or may include a pair of units, connected with a bridge 12, which are configured for insertion into adjacent nasal cavities of the user as shown for example in
The nasal insert 2 further includes a base 50 that is shaped to be received in the interior cavity 6 of the user interface housing. The base 50 defines and includes an exit port 52. A cap 24 is connected to the base and defines and includes an input port 54. The base and cap are configured to fit together, with one or both of the base and cap, alone or in combination, defining an interior passageway 40. A valve member 30 is moveably disposed in the interior passage. As shown in
As shown in
In one embodiment, the cap 24 includes a baffle 26 defining a plurality of valve openings 28, shown as three, arranged around a central opening 36. It should be understood that the baffle may be formed on the base, or separately formed and coupled between the base and cap. In one embodiment, best shown in
In one embodiment, the valve member 30 is configured as an O-ring, which moves reciprocally in the passageway 40 defined by the cap 24 and base 50. In one embodiment, the valve member surrounds and is moveable along a hub 48, which is configured with three fingers in one embodiment and forms part of the baffle 26. The three fingers help control and maintain the alignment of the O-ring valve member along a centerline of the assembly. In an inspiration position, shown in
During exhalation as shown in
The cap 24 and base 50 are coupled together, for example with a snap fit. As shown in FIGS. 4 and 15-19, the base may have a pair of resilient arms 58 that interface and slide along a pair of recesses 60 until the arms are engaged with the cap by way of a snap fit, with the base having an outer annular skirt 62 overlapping an inner annular skirt 64 of the cap. Of course, the overlap may be reversed. The user interface is then disposed over one or both of the cap and base, and may further secure, or maintain the coupling between, those components one to the other. The user interface 4 may be secured by way of friction, or with adhesives or other fasteners such as the tab 14 and recess 16 interface or rim 22.
Referring to the embodiment of
In an alternative embodiment, shown in
In an alternative embodiment, shown in
Referring to
Referring to
In one embodiment, shown in
Referring to the embodiment shown in
Referring to
In operation, and referring to
The opposite end of the handle may also be used for insertion/extraction. For example, the magnet 520 may attract a nasal insert, which may then be manipulated and inserted into a vestibule. The handle 502 may then be twisted or turned to disengage the magnet 520. The nasal insert may be extracted by first engaging the handle 502 through a magnetic attraction with the nasal insert, with the handle 520 and insert then being moved away from the vestibule.
Referring to
A valve 306 is in communication with the interior passage 312. The valve 306 limits a fluid flow through the interior passage in at least one direction. In one embodiment, the valve 306 is configured as a hinged flap covering one end of the interior passage. As shown in
As shown in
Referring to
Referring to the embodiments of
In various embodiments, especially where configured as a single insert without a bridge providing stability, one or more interior, annular ribs 432, shown as three in one embodiment (
The use of separate inserts may be particularly advantageous for users that, due to anatomical structure or nasal injury, use only one nostril for inhalation/exhalation. In addition, some users may have different internal heights in the vestibule area, thereby allowing the user to customize the individual insert to be used in each nasal cavity.
Referring to
Each insert 602 has an inlet port opening into an interior space. One or more of the flaps 604 will open to allow inhaled air to flow from the interior space to the patient's lungs. There is very little resistance, e.g., less than 2 cm of water, during inhalation. Upon exhalation, the flaps 604 are closed such that the exhaled air is directed along the outer surface of the flaps. The air travels down a circular, spiral flow path 616 defined by and between the spiral rib 612 and the nasal vestibule tissue engaged therewith, which creates a tortuous flow path for the exhaled air. The tortuous flow path produces a resistance to exhaled air flow which in turn creates an increased air pressure in the patient's respiratory system. The increase in pressure will be in the range between 5 and 20 cm of water. The spiral rib 612 may also be easily compressed such that the nasal tissue is partially allowed to settle in between the spiral rib and help maintain the nasal insert in the nasal cavity.
Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. As such, it is intended that the foregoing detailed description be regarded as illustrative rather than limiting and that it is the appended claims, including all equivalents thereof, which are intended to define the scope of the invention.
Claims
1-36. (canceled)
37. A nasal insert comprising:
- a housing defining an interior space and comprising an end portion having a plurality of petal shaped flaps, said flaps moveable between an inhalation position wherein a first opening is defined by and between one or more of said flaps, and an exhalation position, wherein end portions of said flaps are disposed adjacent one another.
38. The nasal insert of claim 37 wherein said housing further comprises an annular housing connected to said flaps, wherein a spiral rib is formed circumferentially around an outer surface of said annular housing.
39. The nasal insert of claim 37 wherein said flaps are defined by slits formed in said housing therebetween.
40. The nasal insert of claim 37 further comprising a second opening formed between said end portions of said flaps when said flaps are in said exhalation position, wherein said second opening defines in part said first opening.
41. A nasal insert comprising:
- a user interface comprising a circumferential wall defining an interior passageway and an exterior surface adapted to interface with a nasal vestibule of a user, said exterior surface defining an exhalation flow path; and
- a valve in communication with said interior passageway, said valve limiting a fluid flow through said interior passage during exhalation.
42. The nasal insert of claim 41 wherein said exterior surface comprises a spiral rib defining said exhalation flow path.
43. The nasal insert of claim 41 wherein said user interface defines a longitudinal axis, and wherein said exterior surface has a longitudinally extending recess defining said exhalation flow path.
44. The nasal insert of claim 43 wherein said exterior surface has a plurality of said longitudinally extending recesses circumferentially spaced around said exterior surface.
45. The nasal insert of claim 41 wherein said valve comprises a hinged flap covering one end of said interior passageway.
46. The nasal insert of claim 45 wherein said valve comprises a plurality of petal shaped flaps, said flaps moveable between an inhalation position wherein a first opening is defined by and between one or more of said flaps, and an exhalation position, wherein end portions of said flaps are disposed adjacent one another.
47. The nasal insert of claim 46 wherein said flaps are defined by slits formed in said user interface therebetween.
48. The nasal insert of claim 46 further comprising a second opening formed between said end portions of said flaps when said flaps are in said exhalation position, wherein said second opening defines in part said first opening.
49. The nasal insert of claim 45 further comprising a grippable handle coupled to said user interface opposite said hinged flap.
50. A method of providing resistance during exhalation comprising:
- providing a housing comprising a circumferential wall defining an interior passage and having a contoured exterior surface;
- inserting said housing into a nasal vestibule of a user;
- engaging a tissue of said nasal vestibule with said contoured exterior surface and thereby forming an exhalation flow path between said tissue and said contoured exterior surface;
- inhaling through said housing and passing air through a valve in communication with said interior passage;
- exhaling through said housing and limiting a flow of exhaled air through said interior passage with said valve; and
- passing at least a portion of said exhaled air through said exhalation path between said tissue and said contoured exterior surface.
51. The method of claim 50 wherein said contoured exterior surface comprises a spiral rib defining said exhalation flow path.
52. The method of claim 50 wherein said housing defines a longitudinal axis, and wherein said contoured exterior surface has a longitudinally extending recess defining said exhalation flow path.
53. The method of claim 52 wherein said contoured exterior surface has a plurality of said longitudinally extending recesses circumferentially spaced around said exterior surface.
54. The method of claim 50 wherein said valve comprises a hinged flap covering one end of said interior passageway, wherein said passing air through said valve during inhalation comprises pivoting said flap about said hinge.
55. The method of claim 50 wherein said valve comprises a plurality of petal shaped flaps, wherein said passing air through said valve during inhalation comprises moving one or more of said flaps so as to define a first opening, and wherein said limiting said flow of exhaled air through said interior passage with said valve comprises disposing end portions of said flaps adjacent one another.
56. The method of claim 55 wherein said flaps are defined by slits formed in said housing therebetween.
57. The method of claim 55 wherein said housing has a second opening formed between said end portions of said flaps when said flaps are adjacent one another in an exhalation position, and wherein said limiting said flow of exhaled air through said interior passage comprises permitting a limited flow of exhaled air through said second opening and into said interior passage when said flaps are in said exhalation position, and wherein said second opening defines in part said first opening.
Type: Application
Filed: Sep 28, 2012
Publication Date: Apr 4, 2013
Patent Grant number: 9730830
Inventors: MARTIN P. FOLEY (London), Jerry R. Grychowaski (Lake Zurich, IL)
Application Number: 13/629,921
International Classification: A61F 5/56 (20060101);